(79 days)
No
The device description and performance studies focus on mechanical and filtration aspects of blood processing during cardiopulmonary bypass, with no mention of AI or ML technologies.
No.
The device collects, defoams, and filters blood during cardiopulmonary bypass. It does not exert a therapeutic effect on the patient.
No
The device description indicates its function is to collect, defoam, and filter blood during cardiopulmonary bypass. This is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a "system, including a blood reservoir consisting of an hardshell and softshell reservoir" and mentions physical components like "defoaming bodies and filtering media." The performance studies also detail testing of mechanical properties and physical characteristics, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "collecting, defoaming and filtering venous and suction blood during cardiopulmonary bypass." This is a process performed on the patient's blood outside the body during a medical procedure, not a test performed on a sample of blood to diagnose a condition or provide information about a patient's health status.
- Device Description: The description details a system for handling blood during surgery, including reservoirs, defoaming bodies, and filtering media. This aligns with a device used in a medical procedure, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing blood components, detecting biomarkers, or providing any kind of diagnostic information. The function is purely mechanical (collecting, defoaming, filtering).
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Quantum Perfusion Hybrid System does not fit this description. It's a device used in a surgical procedure to manage blood flow.
N/A
Intended Use / Indications for Use
The Quantum Perfusion Hybrid System is intended to collect, defoam and filter venous and suction blood during cardiopulmonary bypass. The device is intended to be used for periods up to six hours. The device is intended for adult patients.
Product codes (comma separated list FDA assigned to the subject device)
DTN
Device Description
The Quantum Perfusion Hybrid System is a system, including a blood reservoir consisting of an hardshell and softshell reservoir.
The combination of defoaming bodies and filtering media of venous/vent and cardiotomy side allows both the filtration of debris and the retention of air bubbles. Product configuration includes, together with the Hybrid System, dedicated spare parts:
- . an adapter 1/2" – 3/8";
- a spare cap set;
- . a blood sampling set.
The device is intended to be used for periods up to six hours.
The Quantum Perfusion Hybrid System is a sterile device with non-pyrogenic fluid pathways, sterilized by ethylene oxide, conceived for single use only and is not to be re-sterilized by the user; the device has a declared shelf life of 2 years.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
NON-CLINICAL TESTING
The following non-clinical testing was performed to support the substantial equivalence to predicate devices. These testing included biocompatibility evaluation, mechanical and performance verification, labeling and Instructions for Use (IFU), and verification and validation tests. All testing passed by meeting the established requirements set for the use of the devices.
The following areas have been tested and/or evaluated:
- l Performance tests, taking into account:
- ISO 15674:2016+A1: 2020 Cardiovascular implants and artificial organs o — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags;
- Guidance for Extracorporeal Blood Circuit Defoamer 510(k) o Submissions; Final Guidance for Industry and FDA, dated November 29, 2000.
Tests are mainly related to:
- -Device pressure drop;
- -Temperature Probe Verification;
- Mechanical Resistance of Connectors; -
- -Static Integrity of The Device;
- Coating Coverage and Durability; -
- -Mechanical Blood Cell Damage;
- Air Handling, Clots Inspection and Defoaming Efficiency; -
- -Static and Dynamic Priming Volume;
- -Breakthrough Time and Volume;
- -Filtration Efficiency.
- -Evaluation of product shelf life;
- -Validation of the EtO Sterilization process, according to ISO 11135 [Recognition Nr.: 14-529],
- -Packaging Validation tests, according to ISO 11607-1:2019 [Recognition Nr. 14-530],
- -Biocompatibility of the finished product, according to ISO 10993-1:2018 [Recognition Nr. 2-258] and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
Animal Study
No animal studies have been performed except for mandatory biocompatibility tests according to International Standard ISO 10993-1:2018 [Recognition Nr. 2-258] and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
Clinical Testing
No clinical data have been included in the current 510(k) submission to support substantial equivalence to legally marketed predicate and reference devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.4400 Cardiopulmonary bypass blood reservoir.
(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 18, 2024
Spectrum Medical S.r.1. Raffaella Tommasini QA&RA Director Via di Mezzo, 23 Mirandola, MO 41037 Italy
Re: K241206
Trade/Device Name: Ouantum Perfusion Hybrid System Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiopulmonary Bypass Blood Reservoir Regulatory Class: Class II Product Code: DTN Dated: April 29, 2024 Received: April 30, 2024
Dear Raffaella Tommasini:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Nicole M. Gillette -S
Nicole Gillette Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K241206
Device Name Quantum Perfusion Hybrid System
Indications for Use (Describe)
The Quantum Perfusion Hybrid System is intended to collect, defoam and filter venous and suction blood during cardiopulmonary bypass. The device is intended to be used for periods up to six hours. The device is intended for adult patients.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for Spectrum Medical. The text "Spectrum" is in blue, followed by a red heartbeat symbol. The word "Medical" is in blue and follows the heartbeat symbol.
510(K) SUMMARY
l. SUBMITTER
| Submitter Name: | Spectrum Medical S.r.l. |
|---|---|
| Submitter Address: | Via di Mezzo, 23 41037 Mirandola (MO) Italy |
| Contact Person: | Raffaella Tommasini, QA&RA Director |
| Spectrum Medical S.r.l. | |
| Phone: | +39 0535 1803050 |
| e-mail: | raffaella.tommasini@spectrummedical.com |
| Fax: | +39 0535 1803051 |
| Date Summary Prepared: | April 29, 2024 |
and Vascular Devices)
ll. DEVICE
Proprietary Name: Common Name: Classification Name: Regulatory Class: Product Code: Panel:
Quantum Perfusion Hybrid System Hybrid System Reservoir, Blood, Cardiopulmonary Bypass ll DTN Office office office Cardiovascular Devices, Health Technology 2 (OHT2) / Division of Health Technology 2 B (Circulatory Support, Structural
4
Image /page/4/Picture/0 description: The image shows the logo for Spectrum Medical. The text "Spectrum" is in blue, followed by a red line that resembles a heart rate monitor. The word "Medical" is in blue and follows the red line.
PREDICATE DEVICES AND REFERENCE DEVICES III.
| Predicate Device | |
|---|---|
| Proprietary Name: | INSPIRE 8F DUAL hollow Fiber Oxygenator with |
| Integrated arterial filter and hardshell | |
| venous/cardiotomy reservoir | |
| Registered Establishment Name: | Sorin Group Italia S.r.l. |
| Classification Name: | Cardiopulmonary Bypass Oxygenator, Reservoir, |
| Blood, Cardiopulmonary Bypass | |
| Regulatory Class: | II |
| Product Code: | DTN,DTZ |
| 510(k) Number: | K122844 |
Reference Device
| Proprietary Name: | Affinity Fusion™ Oxygenator with Integrated
Arterial Filter and Cardiotomy/Venous Reservoir
with Balance™ Biosurface |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Registered Establishment Name: | Medtronic Inc. |
| Classification Name: | Cardiopulmonary bypass Oxygenator |
| Regulatory Class: | II |
| Product Code: | DTZ |
| 510 (k) Number: | K183490 |
DEVICE DESCRIPTION IV.
The Quantum Perfusion Hybrid System is a system, including a blood reservoir consisting of an hardshell and softshell reservoir.
The combination of defoaming bodies and filtering media of venous/vent and cardiotomy side allows both the filtration of debris and the retention of air bubbles. Product configuration includes, together with the Hybrid System, dedicated spare parts:
- . an adapter 1/2" – 3/8";
- a spare cap set;
5
Image /page/5/Picture/0 description: The image shows the logo for Spectrum Medical. The word "Spectrum" is written in blue, followed by "Medical" in the same color. A red line resembling an electrocardiogram (EKG) is placed between the two words, adding a medical connotation to the logo.
- . a blood sampling set.
The device is intended to be used for periods up to six hours.
The Quantum Perfusion Hybrid System is a sterile device with non-pyrogenic fluid pathways, sterilized by ethylene oxide, conceived for single use only and is not to be re-sterilized by the user; the device has a declared shelf life of 2 years.
V. INTENDED USE / INDICATIONS FOR USE
The Quantum Perfusion Hybrid System is intended to collect, defoam and filter venous and suction blood during cardiopulmonary bypass. The device is intended to be used for periods up to six hours. The device is intended for adult patients.
6
Image /page/6/Picture/0 description: The image shows the logo for Spectrum Medical. The word "Spectrum" is written in blue, followed by a red heartbeat symbol. The word "Medical" is written in blue after the heartbeat symbol.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Device | Proposed Device – Quantum
Perfusion Hybrid System | Predicate Device – INSPIRE 8F DUAL
hollow Fiber Oxygenator with
integrated arterial filter and
hardshell venous/cardiotomy
reservoir | Reference Device – Affinity Fusion™
Oxygenator with Integrated Arterial
Filter and Cardiotomy/Venous
Reservoir with Balance™ Biosurface |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Quantum Perfusion Hybrid System | INSPIRE 8F DUAL hollow Fiber
Oxygenator with integrated arterial
filter and hardshell
venous/cardiotomy reservoir | Affinity Fusion™ Oxygenator with
Integrated Arterial Filter and
Cardiotomy/Venous Reservoir with
Balance™ Biosurface |
| 510(k) Number | To be assigned | K122844 | K183490 |
| Device description | The Quantum Perfusion Hybrid
System (HR04V-A0) mainly consists of
two separate chambers: the first
chamber collects and filters the non-
activated blood coming from patient's
vein and the intracardiac suction; The
second chamber collects and filters
the activated blood coming from the
operating field through thoracic and
general suction (cardiotomy line). The
device can also be used post-
operatively for chest drainage. | The INSPIRE 8F DUAL is a high
efficiency microporous hollow fiber
membrane oxygenator integrated
with an arterial filter and a heat
exchanger (INSPIRE 8F M) and
connected to a hardshell
venous/cardiotomy reservoir
(INSPIRE HVR DUAL). A molded filling
joint connects the oxygenator to the
reservoir.
The device can be operated at flow
rates up to 8 liters per minute (l/min).
The hollow fiber membrane
oxygenator provides oxygenation and | The Affinity Fusion Oxygenator with
Integrated Arterial Filter (OXY) and
Balance Biosurface is a single use,
microporous, hollow-fiber, gas-
exchange device with plasma-
resistant fiber and integrated heat
exchanger and filter. The OXY is
bonded on its primary blood
contacting surfaces with a
nonleaching biocompatible surface to
reduce platelet activation and
adhesion and preserve platelet
function. |
| Device | Proposed Device - Quantum Perfusion Hybrid System | Predicate Device - INSPIRE 8F DUAL hollow Fiber Oxygenator with integrated arterial filter and hardshell venous/cardiotomy reservoir | Reference Device - Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance™ Biosurface |
| | The Quantum Perfusion Hybrid System must be used during cardiac surgical procedures requiring cardiopulmonary bypass for a maximum duration of 6 hours and can be operated up to 8 liters per minute (l/min). | carbon dioxide removal from venous blood or suction blood. The integrated heat exchanger controls blood temperature and allows the use of hypothermia or aids in the maintenance of normothermia during surgery. The integrated arterial filter provides additional protection against air and solid emboli and the integrated hardshell reservoir collects, defoams, filters venous and suction blood, and can be used post-operatively for chest drainage. | The Affinity Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the filtered venous blood. With the exception of the filter, the CVR is bonded on its primary venous blood contacting surfaces with a nonleaching biocompatible surface to reduce platelet activation and adhesion and preserve platelet function. |
| Regulation # | 870.4400 | 870.4350 (oxygenator)
870.4400 (reservoir) | 870.4350 (oxygenator)
(Please note that some variants included in K183490 present as additional component a reservoir, for which 870.4400 is applicable) |
| Regulation Name | Reservoir, Blood, Cardiopulmonary Bypass | Cardiopulmonary Bypass Oxygenator Reservoir, Blood, Cardiopulmonary Bypass | Cardiopulmonary Bypass Oxygenator (Please note that some variants included in K183490 present as additional component a reservoir) |
| Device | Proposed Device - Quantum
Perfusion Hybrid System | Predicate Device - INSPIRE 8F DUAL
hollow Fiber Oxygenator with
integrated arterial filter and
hardshell venous/cardiotomy
reservoir | Reference Device - Affinity Fusion™
Oxygenator with Integrated Arterial
Filter and Cardiotomy/Venous
Reservoir with Balance™ Biosurface |
| Product Code | DTN | DTZ (oxygenator), DTN (reservoir) | DTZ (oxygenator)
(Please note that some variants
included in K183490 present as
additional component a reservoir, for
which DTN product code is applicable) |
| Classification | II | II | II |
| Indication for Use | The Quantum Perfusion Hybrid
System is intended to collect, defoam
and filter venous and suction blood
during cardiopulmonary bypass. The
device is intended to be used for
periods up to six hours. The device is
intended for adult patients. | INSPIRE HVR DUAL Hardshell
Venous/Cardiotomy Reservoir is
intended for use in adult and small
adult surgical procedures requiring
cardiopulmonary bypass. It collects,
defoams and filters venous blood and
suction blood.
INSPIRE HVIR DUAL can be used post-
operatively for chest drainage.
INSPIRE HVIR DUAL is intended to be
used for 6 hours or less. | The Affinity Fusion™ Oxygenator with
Integrated Arterial Filter with
Balance™ Biosurface is intended to be
used in an extracorporeal perfusion
circuit to oxygenate and remove
carbon dioxide from the blood and to
cool or warm the blood during routine
cardiopulmonary bypass (CPB)
procedures up to 6 hours in duration.
The Affinity Fusion™ Oxygenator with
Integrated Arterial Filter with
Balance™ Biosurface is designed to
filter from the circuit microemboli
larger than the specified micron size
for periods up to 6 hours during CPB
surgery.
The Affinity Fusion™
Cardiotomy/Venous Reservoir with |
| Device | Proposed Device - Quantum
Perfusion Hybrid System | Predicate Device - INSPIRE 8F DUAL
hollow Fiber Oxygenator with
integrated arterial filter and
hardshell venous/cardiotomy
reservoir | Reference Device - Affinity FusionTM
Oxygenator with Integrated Arterial
Filter and Cardiotomy/Venous
Reservoir with BalanceTM Biosurface |
| | | | BalanceTM Biosurface is intended to be
used in an extracorporeal perfusion
circuit to collect venous and
cardiotomy suctioned blood during
routine cardiopulmonary procedures
up to 6 hours in duration. The CVR is
also intended for use during vacuum-
assisted venous drainage (VAVD)
procedures.
The Affinity FusionTM
Cardiotomy/Venous Reservoir with
BalanceTM Biosurface is also intended
for use after open heart
surgery to collect autologous blood
from the chest and to aseptically
return the blood to the patient for
blood volume replacement. |
| Target population | Adult | Adult and small adult | Adult |
| Main contacting material | Coating: Phosphorylcholine
Filtering media: Polyester (PET)
Defoaming body: Polyurethane (PU)
Housing: Copolyester | Coating: Phosphorylcholine
Filtering media: Polyester (PET)
Defoaming body: Polyurethane (PU)
Housing: Polycarbonate (PC) | Coating: Hydrophilic biosurface
without heparin
Filtering media: Information on
material N.A. |
| Device | Proposed Device - Quantum
Perfusion Hybrid System | Predicate Device - INSPIRE 8F DUAL
hollow Fiber Oxygenator with
integrated arterial filter and
hardshell venous/cardiotomy
reservoir | Reference Device - Affinity Fusion™
Oxygenator with Integrated Arterial
Filter and Cardiotomy/Venous
Reservoir with Balance™ Biosurface |
| | | | Defoaming body: Polyurethane (PU) |
| | | | Housing: Copolyester (Tritan) |
| Overall volume capacity [ml] | 4300 | 4500 | 4500 |
| Min operating level [ml] | 150 | 150 | 200 |
| Max venous blood flow rate
[I/min] | 8 | 8 | 7 |
| Min venous blood flow rate
[I/min] | 1 | 2
0.5 (up to 2h max duration time)1 | 1 |
| Cardiotomy capacity [ml] | 1100 | 1300 | NA |
| Venous section filtration
porosity [µm] | 40 | 41 | 105 |
| Suitable for VAVD | Yes | Yes | Yes |
| Venous Blood Connector | Inlet: 1/2" (12,7mm) | Inlet: 1/2" (12,7mm) | Inlet: 1/2" with 3/8" adapter |
| Type | Outlet: 3/8" (9.525mm) | Outlet: 3/8" (9.525mm) | Outlet: 3/8" |
| Single-use | Yes | Yes | Yes |
| Sterile Condition | Sterile | Sterile | Sterile |
7
Image /page/7/Picture/0 description: The image shows the logo for Spectrum Medical. The word "Spectrum" is written in blue, followed by a red line that resembles a heart rate monitor. The word "Medical" is written in blue after the red line.
Spectrum Medical S.r.l. - Via di Mezzo, 23 - 41037 Mirandola (MO) P.IVA/VAT 03663360364 - Email: info.ITA@spectrummedical.com
8
Image /page/8/Picture/0 description: The image shows the logo for Spectrum Medical. The word "Spectrum" is written in blue, followed by a red line that resembles a heartbeat. The word "Medical" is written in blue after the red line.
9
Image /page/9/Picture/0 description: The image shows the logo for Spectrum Medical. The word "Spectrum" is written in blue, followed by a red line that resembles an EKG. The word "Medical" is written in blue after the red line.
Spectrum Medical S.r.l. - Via di Mezzo, 23 - 41037 Mirandola (MO) P.IVA/VAT 03663360364 - Email: info.ITA@spectrummedical.com
10
Image /page/10/Picture/0 description: The image shows the logo for Spectrum Medical. The word "Spectrum" is written in blue, followed by a red line that resembles a heart rate monitor. The word "Medical" is written in blue after the red line.
1 According to manufacturer's IFU.
Spectrum Medical S.r.l. - Via di Mezzo, 23 - 41037 Mirandola (MO) P.IVA/VAT 03663360364 - Email: info.ITA@spectrummedical.com
11
Image /page/11/Picture/0 description: The image shows the logo for Spectrum Medical. The text "Spectrum" is in blue, followed by a red line that resembles a heartbeat. The word "Medical" is in blue and follows the red line.
Based on the indications for use, main technological characteristics and results of nonclinical testing, subject device has been demonstrated to be appropriate for its intended use and is considered substantially equivalent to legally marketed predicate and reference devices (K122844 and K183490 respectively) according to FDA's Guidance "Evaluating Substantial Equivalence in Premarket Notifications [510(k)]," issued July 28, 2014.
Furthermore, in-vitro performance tests have been performed to demonstrate that the proposed device does not raise any new issues in terms of product's safety or effectiveness as compared to predicate and reference devices.
VII. PERFORMANCE DATA
NON-CLINICAL TESTING
The following non-clinical testing was performed to support the substantial equivalence to predicate devices. These testing included biocompatibility evaluation, mechanical and performance verification, labeling and Instructions for Use (IFU), and verification and validation tests. All testing passed by meeting the established requirements set for the use of the devices.
The following areas have been tested and/or evaluated:
- l Performance tests, taking into account:
- ISO 15674:2016+A1: 2020 Cardiovascular implants and artificial organs o — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags;
- Guidance for Extracorporeal Blood Circuit Defoamer 510(k) o Submissions; Final Guidance for Industry and FDA, dated November 29, 2000.
Tests are mainly related to:
- -Device pressure drop;
- -Temperature Probe Verification;
- Mechanical Resistance of Connectors; -
- -Static Integrity of The Device;
- Coating Coverage and Durability; -
- -Mechanical Blood Cell Damage;
- Air Handling, Clots Inspection and Defoaming Efficiency; -
12
Image /page/12/Picture/0 description: The image shows the logo for Spectrum Medical. The text "Spectrum" is in blue, followed by a red line that resembles a heartbeat. The text "Medical" is in blue and follows the red line.
- -Static and Dynamic Priming Volume;
- -Breakthrough Time and Volume;
- -Filtration Efficiency.
- -Evaluation of product shelf life;
- -Validation of the EtO Sterilization process, according to ISO 11135 [Recognition Nr.: 14-529],
- -Packaging Validation tests, according to ISO 11607-1:2019 [Recognition Nr. 14-530],
- -Biocompatibility of the finished product, according to ISO 10993-1:2018 [Recognition Nr. 2-258] and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
Animal Study
No animal studies have been performed except for mandatory biocompatibility tests according to International Standard ISO 10993-1:2018 [Recognition Nr. 2-258] and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
Clinical Testing
No clinical data have been included in the current 510(k) submission to support substantial equivalence to legally marketed predicate and reference devices.
VIII. CONCLUSIONS
Based on the indications for use, main technological characteristics and results of nonclinical testing, the subject device has been demonstrated to be appropriate for its intended use and considered substantially equivalent to predicate and reference devices (K122844 and K183490 respectively).